Bone Microstructure by Using HR-pQCT After Esophagectomy

Osteoporosis Clinical Trial

Official title:

Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05812235
• Other study ID #: NagasakiU3
• Status: Not yet recruiting
• Start date: May 25, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2023
• Source: Nagasaki University
• Contact: Shinichiro Kobayashi
• Phone: 0958197316
• Email: shinichirokobayashi[@]nagasaki-u.ac.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Esophagectomy is most curative treatment to esophageal cancer. However, osteoporosis , which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after surgery. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after esophagectomy. At least 3 years should have elapsed since operation without recurrence of esophageal cancer.

Description:

The patients after esophagectomy loss appetite and decrease the weight. Esophagectomy especially cause severe sarcopenia and metabolic change. Osteoporosis, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after esophagectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT in the long course after esophagectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after esophagectomy. At least 3 years should have elapsed since esophagectomy without any recurrence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: March 31, 2027
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• At least 3 years have elapsed since esophagectomy due to esophageal cancer

• Provide signed informed consent

Exclusion Criteria:

• Current use of the following osteoporosis agents; Teriparatide, Denosumab, and - -

• bisphosphonate

• Present malignancy (except in situ carcinoma)

• Radiotherapy

• Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy

• Other diseases which affect bone metabolism Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures Received > 3 months (or equivalent) of osteoporosis treatment Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

Related Conditions & MeSH terms

• Esophageal Cancer
• Osteoporosis
• Sarcopenia

Intervention

Procedure:
• esophagectomy
esophagectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nagasaki University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing bone microstructure in control and Esophagectomy groups	volumetric bone mineral density	1day
Secondary	Comparing bone microstructure with serum biomarkers of osteoporosis	Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)	1day
Secondary	Comparing bone microstructure with dual-energy X-ray absorptiometry	Correlation of bone mineral density between esophagectomy and DXA	1day